InfluenzaPhase 3NCT05093998
Study Evaluating the Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza
A Phase 3 study testing AV5080 in people with Influenza, run by Viriom at 6 sites in Russia.
Trial summary
To evaluate the efficacy of AV5080 versus Placebo based on time to symptom resolution in patients with uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- AV5080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 6 sitesRussia
- Study dates
- 15 Jan 2022to 31 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Men and women between the ages of 18 and 65 (inclusive).
- Outpatients (including those admitted at home) and inpatients hospitalized for epidemiological reasons, diagnosed with influenza (ICD 10: J10 Influenza caused by an identified influenza virus) of mild to moderate severity.
- Positive result of the rapid enzyme immunoassay test for influenza virus at screening.
- Increase in body temperature in the armpit up to ≥ 38.0 оС at screening (or within 24 hours before screening according to the patient's words).
- Presence of at least one of the following symptoms of moderate severity on screening:
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- headache, weakness/malaise, muscle pain/aches, fever/chills.
- The duration of the disease is no more than 48 hours at the time of screening according to the patient.
- Consent of patients to use adequate methods of contraception throughout the study.
- Adequate methods of contraception include the use of:
- oral or transdermal contraceptives;
- a condom or diaphragm (barrier method) with spermicide or
- an intrauterine device.
Who cannot join
- Pregnant or lactating women or women planning pregnancy during a clinical study; women capable of childbearing (including menopausal women less than 2 years old) who do not use adequate methods of contraception.
- Individual intolerance to the drug AV5080 or its components. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Presence of complications of influenza, signs of bacterial infection or severe flu at the time of screening.
- Infectious diseases transferred during the last week before screening
- The need for hospital treatment for influenza, with the exception of hospitalization for epidemiological indications.
- Reception of neuraminidase inhibitors (zanamivir and oseltamivir), immunotropic drugs, systemic glucocorticosteroids, antibacterial drugs of systemic action within 1 month before screening. Taking drugs that prolong the QT interval on an ECG (quinidine, amiodarone, procainamide, phenothiazine derivatives) for 5 half-lives or less before screening.
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- A history of influenza vaccination within 3 months prior to screening.
- Chronic diseases of the respiratory system (bronchial asthma, COPD,) in history.
- Persons with metabolic disorders (diabetes mellitus, obesity of 2-3 degrees).
- Hypokalemia at screening (potassium level less than 3.5 mmol/L)
- Persons with chronic kidney disease, chronic liver disease, with certain neurological conditions (including neuromuscular, neurocognitive disorders, epilepsy), hemoglobinopathies or suppressed immune conditions, or due to primary immunosuppressive conditions such as HIV infection, or in connection with secondary immunodeficiency states due to the intake of immunosuppressive medications or malignant neoplasms.
- Significant cardiovascular diseases at present or during 12 months before screening, including: prolongation of the QT interval on ECG more than 450 ms, atrioventricular block, sinus bradycardia, chronic cerebrovascular insufficiency, chronic heart failure class III or IV (according to the classification of the New York Heart Association), severe arrhythmia, requiring treatment with class Ia, Ib, Ic, or III antiarrhythmic drugs, unstable angina pectoris, myocardial infarction, heart and coronary artery surgery, significant heart valve disease, transient ischemic attack or stroke, uncontrolled hypertension with systolic blood pressure> 180 mm Hg ... and diastolic blood pressure> 110 mm Hg, pulmonary embolism or deep vein thrombosis.
- A history of chronic alcoholism, drug addiction or dependence on other chemical compounds.
- Participation in other clinical trials within 3 months prior to screening.
- Inability to read or write; unwillingness to understand and follow research protocol procedures; non-compliance with the regimen of taking medications or performing procedures that, in the opinion of the Investigator, may affect the results of the study or the safety of the patient and prevent the patient from further participation in the study any other comorbid medical or serious mental condition that renders a patient ineligible for participation in a clinical research study, limits the ability to obtain informed consent, or may affect a patient's ability to participate in a study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Specialized Clinical Infectious Diseases Hospital
Krasnodar
Murmansk Regional Clinic named after P.A. Bayandin
Murmansk
Federal Research Center Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
Novosibirsk
Center for the Prevention and Control of AIDS and Infectious Diseases
Saint Petersburg
First Saint Petersburg State Medical University named after I.I. Academician Pavlov
Saint Petersburg
Research Center Eco-safety
Saint Petersburg
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza
To evaluate the efficacy of AV5080 versus Placebo based on time to symptom resolution in patients with uncomplicated influenza.
Read the detailed description
This study is an international, multicenter, double-blind, randomized, placebo-controlled, phase III clinical trial in parallel groups evaluating the efficacy and safety of AV5080 in patients with uncomplicated influenza.
Only patients with mild to moderate influenza, without complications, will be included in the study. Taking into account the seasonality of the pathology and the low percentage of influenza in the general structure of ARVI incidence, for the successful inclusion of all patients in the study during two epidemiological seasons. The study will enroll 700 patients aged 18 to 65 years with a confirmed clinical diagnosis of influenza to treatment (AV5080) and placebo cohorts (1:1).
- Conditions
- Influenza
- Being tested
- AV5080, Placebo
- Keywords
- Treatment for influenza in adults
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV5080Drug
Also called AV5080 at a daily dose of 160 mg
oral hard gelatin capsules
PlaceboOther
Hard gelatin capsules with a white body
| Study group | Role | What they receive |
|---|---|---|
| Group 1. | Experimental | AV5080 at a daily dose of 160 mg Receives: Drug: AV5080 |
| Group 2. | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to symptom resolution
The resolution of influenza symptoms is confirmed by the absence of symptoms or their reduction to mild severity (0-1 points) and a decrease in body temperature in the armpit to ≤ 37.2 °C for at least 24 hours. The time to resolve the flu symptoms is the start time of the 24-hour (or longer) interval.
Measured: 30 days
Secondary outcomes (4)
Profile of changes in influenza virus titer versus time (AUC) for 192 hours (in inpatients)
Measured: 192 hours
Frequency of symptom resolution within 96 hours of initiation of study therapy
Measured: 96 hours
Frequency of elimination of influenza virus before Day 6
Measured: 6 Days
The incidence of complications from influenza
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start15 Jan 2022 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093998
- Sponsor's protocol ID
- FLU-AV5080-03
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT05093998
- Acronym / sponsor ID
- FLU-AV5080-03
- Conditions
- Influenza
- Keywords
- Treatment for influenza in adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of AV5080 versus Placebo based on time to symptom resolution in patients with uncomplicated influenza.
Detailed description
This study is an international, multicenter, double-blind, randomized, placebo-controlled, phase III clinical trial in parallel groups evaluating the efficacy and safety of AV5080 in patients with uncomplicated influenza.
Only patients with mild to moderate influenza, without complications, will be included in the study. Taking into account the seasonality of the pathology and the low percentage of influenza in the general structure of ARVI incidence, for the successful inclusion of all patients in the study during two epidemiological seasons. The study will enroll 700 patients aged 18 to 65 years with a confirmed clinical diagnosis of influenza to treatment (AV5080) and placebo cohorts (1:1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1. | Experimental | Drug: AV5080AV5080 at a daily dose of 160 mg |
| Group 2. | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent.
- Men and women between the ages of 18 and 65 (inclusive).
- Outpatients (including those admitted at home) and inpatients hospitalized for epidemiological reasons, diagnosed with influenza (ICD 10: J10 Influenza caused by an identified influenza virus) of mild to moderate severity.
- Positive result of the rapid enzyme immunoassay test for influenza virus at screening.
- Increase in body temperature in the armpit up to ≥ 38.0 оС at screening (or within 24 hours before screening according to the patient's words).
Key exclusion criteria (15 listed)
- Pregnant or lactating women or women planning pregnancy during a clinical study; women capable of childbearing (including menopausal women less than 2 years old) who do not use adequate methods of contraception.
- Individual intolerance to the drug AV5080 or its components. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Presence of complications of influenza, signs of bacterial infection or severe flu at the time of screening.
- Infectious diseases transferred during the last week before screening
- The need for hospital treatment for influenza, with the exception of hospitalization for epidemiological indications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV5080Also: AV5080 at a daily dose of 160 mgoral hard gelatin capsules | Drug | Group 1. |
| PlaceboHard gelatin capsules with a white body | Other | Group 2. |
Primary outcome
Time to symptom resolution
Time frame: 30 days
The resolution of influenza symptoms is confirmed by the absence of symptoms or their reduction to mild severity (0-1 points) and a decrease in body temperature in the armpit to ≤ 37.2 °C for at least 24 hours. The time to resolve the flu symptoms is the start time of the 24-hour (or longer) interval.
4 secondary outcomes
Profile of changes in influenza virus titer versus time (AUC) for 192 hours (in inpatients)
Time frame: 192 hours
Frequency of symptom resolution within 96 hours of initiation of study therapy
Time frame: 96 hours
Frequency of elimination of influenza virus before Day 6
Time frame: 6 Days
The incidence of complications from influenza
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AV5080 in people with Influenza, run by Viriom at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yulia Trakhtenberg, PhD (+7 (495) 276-11-43, jat@ipharma.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to symptom resolution (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.